Bausch & Lomb Incorporated
Form 483 issued February 27, 2025 · Greenville, South Carolina
- Inspection
- Feb 25 – Feb 27, 2025
- Investigators
- Amatul H. Marium· Annet R. Rajan· Daniel L. Zheng
- Observations
- 4
- Pages
- 29
- FEI number
- 1032500
In short: On February 27, 2025, FDA issued a Form 483 with 4 observations to Bausch & Lomb Incorporated in Greenville, South Carolina (FEI 1032500) after an inspection that ran Feb 25 – Feb 27, 2025. The investigators were Amatul H. Marium, Annet R. Rajan, Daniel L. Zheng, Linda Thai, Luxuly Abraham, Ogechi C. Nna, Philip F. Istafanos, Raihan A. Chowdhury, Saundrea A. Munroe and Tanya R. Syffrard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Amatul H. Marium
8 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmBausch & Lomb Incorporated history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bausch & Lomb Incorporated?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Bausch & Lomb Incorporated?
Amatul H. Marium, Annet R. Rajan, Daniel L. Zheng, Linda Thai, Luxuly Abraham, Ogechi C. Nna, Philip F. Istafanos, Raihan A. Chowdhury, Saundrea A. Munroe and Tanya R. Syffrard are named on this Form 483, for the inspection of Feb 25 – Feb 27, 2025. Each investigator has a profile showing what they cite most.
When was Bausch & Lomb Incorporated inspected by FDA?
The inspection ran Feb 25 – Feb 27, 2025, and the Form 483 is dated February 27, 2025.
How do I get the full Form 483 for Bausch & Lomb Incorporated?
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